MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-19 for IBAL UKA FEM CEMENTED SIZ 3,L-MEDIAL AR-501-UFLC manufactured by Arthrex, Inc..
[127857281]
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation. The cause of the event could not be determined from the information available and without device evaluation.
Patient Sequence No: 1, Text Type: N, H10
[127857282]
It was reported by the patient's legal representative that the patient had undergone a left knee menisectomy and chondroplasty on (b)(6) 2015. Thereafter, on (b)(6) 2015 the patient had a hemi-arthroplasty on her left knee. The records provided list that the following arthrex products were implanted during the (b)(6) 2015 procedure: ar-501-ttlb ibalance uni-tibial tray (lot 108761228), ar-501-uflc ibalance uni-femoral implant (lot 1470559) and ar-501-tbb0 ibalance uka tibial bearing (lot 77941142). On (b)(6) 2015 the patient underwent another surgery converting the uni-knee to a total knee replacement. According to the medical records the pre-op diagnosis, and x-ray findings prior to the (b)(6) 2015 procedure note a loose femoral component. However, the operative report notes that the tibial baseplate was loose, not the femoral component. During the procedure the hemi-arthroplasty implants were removed and the following left tka ibalance system components were implanted: ar-503-tttd tibial baseplate (lot 1297044), ar-517-4l femoral implant (lot 1438430), ar-503-a313 tibial bearing implant (13mm) (lot 113601414) and ar-504-psa8 patella implant (lot 113601322). Another manufacturer's bone cement was used with the arthrex implants. The medical records provided note that the patient? S bmi was 38+ which is a contraindication for both the uni and tka devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2018-00762 |
| MDR Report Key | 8086820 |
| Date Received | 2018-11-19 |
| Date of Report | 2018-11-19 |
| Date of Event | 2015-11-06 |
| Date Mfgr Received | 2018-10-24 |
| Date Added to Maude | 2018-11-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | VIK BAJNATH |
| Manufacturer Phone | 8009337001 |
| Manufacturer G1 | ARTHREX, INC. |
| Manufacturer Street | 1370 CREEKSIDE BOULEVARD |
| Manufacturer City | NAPLES FL 341081945 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 341081945 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | IBAL UKA FEM CEMENTED SIZ 3,L-MEDIAL |
| Generic Name | PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER |
| Product Code | KRR |
| Date Received | 2018-11-19 |
| Model Number | IBAL UKA FEM CEMENTED SIZ 3,L-MEDIAL |
| Catalog Number | AR-501-UFLC |
| Lot Number | 1470559 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | 1370 CREEKSIDE BOULEVARD NAPLES FL 341081945 US 341081945 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-19 |